BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2852386 · Received November 27, 2012

    Report

    Report Number
    9613350-2012-01103
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    August 13, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WITH THE INFO GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. BASED ON AN EXTENSIVE INVESTIGATION OF EVENTS REPORTED FROM SEVERAL USER FACILITIES OUTSIDE THE U.S., ZIMMER IDENTIFIED THAT THE MOST PROBABLE CAUSE FOR THE OUTCOME OBSERVED WAS A LOOSE OR UNSTABLE CUP THAT RESULTED FROM USE OF SURGICAL TECHNIQUES NOT CONSISTENT WITH THE MFR'S RECOMMENDATIONS. AS A CORRECTIVE ACTION, A RETRAINING PROGRAM FOR USERS OUTSIDE THE U.S. WAS INITIATED IN NOVEMBER 2009 AND REPORTED TO THE NATIONAL COMPETENT AUTHORITIES AS REQUIRED. THE DUROM CUP REPORTED IN THIS CASE IS NOT MARKETED IN THE U.S. A SIMILAR CUP, COMPATIBLE WITH THE METASUL LDH FEMORAL HEAD, IS CLEARED IN THE U.S. AND A CORRECTIVE ACTION FOR THIS PRODUCT WAS REPORTED TO THE FDA IN 07/2008 AS CORRECTION Z-2415/2426-2008. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED ONCE THE DEVICE BE RETURNED TO THE MFR AND THE FINAL REPORT BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN DUROM ACETABULAR COMPONENT 56/50 CODE P IN 2005 (EXACT DATE NOT REPORTED) AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH TBC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R